Head of Regulatory Affairs

Posted 24 August 2022
LocationDortmund
Job type Permanent
Discipline Regulatory
Reference65337
Contact NameJosh Greaves

Job description

Head of Regulatory Affairs

 

Introduction

A mid-size, well established Medical Device company based in Germany is searching for a talented, experienced Head of Regulatory Affairs. This organisation boasts a wide range of Class I – II OTC Medical Device products treating conditions such as colds, eczema, dry eyes, allergies and more.

This role will offer you

  • The opportunity to stable, long-running family business

  • Opportunity for growth in your career with role progression and education

  • Opportunity to work with a broad product portfolio

You will be responsible for

  • Reporting to C-Suite Leadership Global Regulatory Strategy Ideas

  • Oversee and Implement Global Regulatory Submissions (EU, Middle East, US)

  • Technical File Creation and Review

  • Vigilance Reporting

  • Working Cross-Functionally with Product Development and Marketing from Regulatory Affairs Perspective

You will bring the following

  • Extensive Experience in Regulatory Affairs in Medical Devices / OTC Products

  • Global Regulations Knowledge (EMEA / US)

  • Experience in Smaller Organisations with Flat Hierarchical Structures

  • Experience as Point of Contact for Notified Body

 

BioTalent Ltd are acting as an employment agency in relation to this opportunity.